BRIDGE-US: Bridging Readiness in Deployed Neurotrauma Gaps for Excellence

NCT07636213 | Not Yet Recruiting

• 2 other identifiers: IRB25-0888Medical Technology Enterprise
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to prospectively collect biospecimens, imaging, and clinical data from patients with penetrating brain injuries across high-volume PBI sites in the US (including UChicago). Biospecimens will undergo biomarker analysis - biomarker data specific to PBI is extremely limited, and could provide critical insight to outcome identification and clinical decision making. This data will be used to build the first comprehensive PBI Data Commons, biorepository, and imaging repository which will create the infrastructure necessary to close critical knowledge gaps, advance biomarker discovery specific to PBI, and provide the foundation for future research aimed at improving prognostication and treatment for patients with this devastating injury.

Conditions

Brain Injuries, Acute; Brain Trauma; Penetrating Head Injury; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Building the first PBI Data Commons, Biorepository, and Imaging Repository

  The primary objective of this prospective study is to build the first comprehensive PBI Data Commons, Biorepository, and Imaging Repository. Clinical data, biospecimens, and imaging from subjects with PBI will be prospectively collected and analyzed across multiple sites, which will then be used to build these resources.

  3 months

Secondary Outcomes (1)

• Quantitative biomarker analysis using validated laboratory assays conducted at Orlando Health and Mayo Clinic Laboratories.

  3 months

Interventions

Blood Sample Collection OTHER

Subjects with confirmed Penetrating Brain Injury (PBI) will be enrolled upon arrival to each site and have blood samples collected at five timepoints by nurses/phlebotomists/approved research personnel. As soon as possible after injury, preferably within 4 hours of injury, but must be obtained within 8 hours of injury.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with confirmed PBI.

You may qualify if:

• Age: Subjects aged 16 years and older
• Injury Type/Evidence: Patients with a confirmed PBI as demonstrated by head imaging or physical exam (evidence of dural penetration by a projectile)
• Timeframe: Patients must be enrolled within 8 hours of injury

You may not qualify if:

• No subjects will be excluded based on gender or ethnicity for this study. Subjects under the age of 16 will be excluded. These subjects differ significantly in terms of neurodevelopment, physiology, and trauma response, which introduces heterogeneity that could confound study results. Additionally, pediatric PBI has distinct etiologies, treatment pathways, and prognostic indicators compared to adult PBI (note that age 16 and up are treated medically as adults).
• Dead on Arrival (DOA): Patients who receive CPR with no return of pulse
• Non-penetrating injury: Patients with head injuries that do not include dural penetration
• Polytrauma: Patients with penetrating or blunt injuries to other parts of the body
• Known or suspected pregnancy
• Known or suspected prisoner

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic; Head Injuries, Penetrating

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Wounds, Penetrating

Central Study Contacts

Hugh Flynn

CONTACT

773-834-9627; Hugh.Flynn@bsd.uchicago.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

US (1)